Supreme Court’s Decision is a Gene-Patent Gambit Says Professor Daryl Lim at Chicago’s John Marshall Law School

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The Supreme Court recently gave its answer of “No” to the question of whether human genes were patent-eligible subject matter. The decision relegates industry reliance on the Patent Office’s grant of more than 3,000 patents over 30 years to a footnote for Congressional action.

The Supreme Court recently gave its answer of “No” to the question of whether human genes were patent-eligible subject matter. The decision relegates industry reliance on the Patent Office’s grant of more than 3,000 patents over 30 years to a footnote for Congressional action. But with both sides quick to claim victory, there is more than meets the eye says Intellectual Property Law Professor Daryl Lim of The John Marshall Law School in Chicago.

The Supreme Court has unanimously held that isolated human DNA is not patent-eligible subject matter, but that “synthetic” complementary DNA, or cDNA, molecules are.

“The decision reflects a continuing shift in the Court’s perception of its role in the patent debate. With the Federal Circuit increasingly divided in its jurisprudence, we can expect to see more instances of robust Supreme Court intervention in the future,” predicts Professor Daryl Lim of The John Marshall Law School in Chicago.

In Assoc. for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013), the Court “attempted to walk the tightrope” on an issue that has deeply divided those who say that the protection is appropriate and necessary to spur innovation, and others who warn that protection would smother research and cut off critical access to life-saving diagnostic tests, Lim explains.

Utah-based Myriad Genetics held patents over BRCA1 and BRCA2, two genes whose mutations can lead to breast and ovarian cancer.

“While it may seem odd to think of genes as anything but a product of nature, both the Patent and Trademark Office and the Court of Appeals for the Federal Circuit agreed that Myriad deserved patents for finding the precise location of the genes, isolating them from living cells, and making them suitable for laboratory use,” he noted.

Myriad’s patents gave it the exclusive right to extract and isolate the genes, administer tests and create synthetic DNA. The American Civil Liberties Union (ACLU) led opponents of Myriad’s patents on a long legal campaign through the court system since 2009.

Reversing the Federal Circuit in part, Supreme Court Associate Justice Clarence Thomas, writing for the Court, held that snipping “an important and useful gene” from the genome and altering it as Myriad did was insufficient to make it a “new and useful… composition of matter” deserving of a patent. On the other hand, cDNA was sufficiently synthetic to warrant a patent, even though the Court conceded that it contained the same information as naturally-occurring DNA molecules, and that its sequences was also dictated by nature.

“The Court treated the claims on isolated genes as being directed to information encoded in the genes rather than a chemical composition of specific molecules, and drew the line in the sand there,” the intellectual property law professor noted. “It could have done a better job at distinguishing between cDNA and isolated DNA, and more generally, at articulating a coherent framework for patent eligible matter.

“Still, the decision provides a useful data point. More importantly, it provides some guidance to lower courts while balancing a delicate policy compromise,” he said.

Both sides were quick to claim victory. ACLU lawyers hailed the decision as striking down “a major barrier to patient care and medical innovation,” as “second opinion” testing and broader forms of research will now be allowed.

Myriad, which spent $500 million on research and the commercialization of its research on those genes, issued a press statement touting that while five patents were invalidated, its stable of 500 “valid and enforceable” claims provided it with sufficiently robust rights.

Lim notes that doctors and researchers need the informational content of genes for basic research and diagnostic testing, and patents over genes are difficult to invent around. “The ruling makes it easier to develop personalized medical test and therapy combinations as there are fewer patents to navigate around.”

At the same time, the Court recognized that the U.S. biotech industry, worth more than $90 billion dollars, has moved on from the arena of soon-to-expire human genes patents. Firms today are much more interested on recombinant DNA, which involves snipping and pasting DNA from different sources to make sequences not found in nature.

“While these should be generally eligible, patent drafters today would do well to frame gene claims in terms of their chemical structures,” Lim cautions.    

Myriad’s own patents were set to expire in 2015. But patents on naturally occurring human gene sequences only account for about 10% of all gene patents, Lim noted, and biotech firms like Myriad have valuable data on gene mutations locked away as trade secrets.

Also of interest are correlations between genes to determine the cause of diseases or how well drugs work on individuals. “These are very valuable to biotech companies,” he said.

The Court stressed that patents continue to be available on innovative methods of manipulating genes and new applications of knowledge about BRACA 1 and BRACA2.

“Companies seeking method patents will need to grapple with the Court’s decision in another recent case brought by the Mayo Clinic, which raised the bar,” he cautions. It is unclear how much of the Court’s earlier concern over preempting future innovation survives, or how much alteration is needed before something is sufficiently “synthetic” given a different set of facts.

“It is interesting that the Court considered and then disregarded the views of two specialist bodies.” Lim observes. “Accepting the Solicitor General views on the technology was a calculated gambit,” Lim said.

“In a lone concurrence, Justice (Antonin) Scalia admitted that even though he agreed with the majority’s conclusion, he wasn’t in a position to endorse its understanding and explanation of the technology.”

Daryl Lim is a law professor at The John Marshall Law School in Chicago. He specializes in intellectual property and antitrust law.

About The John Marshall Law School
The John Marshall Law School, founded in 1899, is an independent law school located in the heart of Chicago’s legal, financial and commercial districts. Through classes, clinics and special programs, students develop the strategic, analytical and transactional lawyering skills that are so valuable to employers. Its excellent curriculum, coupled with outstanding skills and experiential learning, help make John Marshall graduates practice-ready from day one. For practicing attorneys, John Marshall offers nine LLM degrees, more than any other law school in the Midwest. John Marshall is also a leader in providing distance education options in intellectual property, estate planning and employee benefits at the advanced graduate degree level. John Marshall offers six clinical experiences, including the nationally recognized Veterans Legal Support Center & Clinic and the Fair Housing Legal Clinic. U.S. News & World Report’s America’s Best Graduate Schools 2014 edition ranks John Marshall’s Lawyering Skills Program second and its Intellectual Property Law program 12th in the nation.

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